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Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance · European Union

8.3. Skin sensitisation The assessment of this endpoint shall comprise the following consecutive steps: 1. an assessment of the available human, animal and alternative data 2. in vivo testing The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided Step 2 does not need to be conducted if: the available information indicates that the substance should be classified for skin sensitisation or corrosivity, or the substance is a strong acid (pH < 2,0) or base (pH > 11,5)

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.